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Last Updated: March 19, 2024

KYPROLIS Drug Patent Profile


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When do Kyprolis patents expire, and when can generic versions of Kyprolis launch?

Kyprolis is a drug marketed by Onyx Pharms Amgen and is included in one NDA. There are eleven patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and nineteen patent family members in forty-two countries.

The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Kyprolis

A generic version of KYPROLIS was approved as carfilzomib by DR REDDYS on September 9th, 2019.

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Drug patent expirations by year for KYPROLIS
Drug Prices for KYPROLIS

See drug prices for KYPROLIS

Recent Clinical Trials for KYPROLIS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Dong-A University HospitalPhase 2
GlaxoSmithKlinePhase 2
PfizerPhase 1

See all KYPROLIS clinical trials

Pharmacology for KYPROLIS
Drug ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors
Paragraph IV (Patent) Challenges for KYPROLIS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KYPROLIS For Injection carfilzomib 10 mg/vial 202714 1 2018-11-28
KYPROLIS For Injection carfilzomib 30 mg/vial 202714 1 2017-10-05
KYPROLIS For Injection carfilzomib 60 mg/vial 202714 9 2016-07-20

US Patents and Regulatory Information for KYPROLIS

KYPROLIS is protected by twenty US patents.

Patents protecting KYPROLIS

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: KYPROLIS IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DARATUMUMAB PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY

Composition for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: KYPROLIS IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DARATUMUMAB PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: KYPROLIS IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DARATUMUMAB PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY

Compounds for enzyme inhibition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE IN COMBINATION WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for KYPROLIS

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Amgen Europe B.V. Kyprolis carfilzomib EMEA/H/C/003790
Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Authorised no no yes 2015-11-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for KYPROLIS

When does loss-of-exclusivity occur for KYPROLIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 05243140
Estimated Expiration: ⤷  Try a Trial

Patent: 05243168
Estimated Expiration: ⤷  Try a Trial

Patent: 05313975
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 99109
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0510802
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 65407
Estimated Expiration: ⤷  Try a Trial

Patent: 66839
Estimated Expiration: ⤷  Try a Trial

Patent: 89921
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1014612
Estimated Expiration: ⤷  Try a Trial

Patent: 1180071
Estimated Expiration: ⤷  Try a Trial

Patent: 2847136
Estimated Expiration: ⤷  Try a Trial

Patent: 2875642
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 11489
Estimated Expiration: ⤷  Try a Trial

Patent: 14025
Estimated Expiration: ⤷  Try a Trial

Patent: 15605
Estimated Expiration: ⤷  Try a Trial

Patent: 17507
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 19353
Estimated Expiration: ⤷  Try a Trial

Patent: 30981
Estimated Expiration: ⤷  Try a Trial

Patent: 60835
Estimated Expiration: ⤷  Try a Trial

Patent: 61236
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 56079
Estimated Expiration: ⤷  Try a Trial

Patent: 58921
Estimated Expiration: ⤷  Try a Trial

Patent: 19353
Estimated Expiration: ⤷  Try a Trial

Patent: 30981
Estimated Expiration: ⤷  Try a Trial

Patent: 60835
Estimated Expiration: ⤷  Try a Trial

Patent: 61236
Estimated Expiration: ⤷  Try a Trial

Patent: 64834
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2005026556
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 07948
Estimated Expiration: ⤷  Try a Trial

Patent: 27618
Estimated Expiration: ⤷  Try a Trial

Patent: 51966
Estimated Expiration: ⤷  Try a Trial

Patent: 52047
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 27850
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 9020
Estimated Expiration: ⤷  Try a Trial

Patent: 3607
Estimated Expiration: ⤷  Try a Trial

Patent: 4776
Estimated Expiration: ⤷  Try a Trial

Patent: 6171
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 90155
Estimated Expiration: ⤷  Try a Trial

Patent: 08509
Estimated Expiration: ⤷  Try a Trial

Patent: 07537265
Estimated Expiration: ⤷  Try a Trial

Patent: 07538081
Estimated Expiration: ⤷  Try a Trial

Patent: 08522981
Estimated Expiration: ⤷  Try a Trial

Patent: 12121895
Estimated Expiration: ⤷  Try a Trial

Patent: 14141456
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 19353
Estimated Expiration: ⤷  Try a Trial

Patent: 30981
Estimated Expiration: ⤷  Try a Trial

Patent: 60835
Estimated Expiration: ⤷  Try a Trial

Patent: 61236
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 19353
Estimated Expiration: ⤷  Try a Trial

Patent: 30981
Estimated Expiration: ⤷  Try a Trial

Patent: 60835
Estimated Expiration: ⤷  Try a Trial

Patent: 61236
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 84585
Estimated Expiration: ⤷  Try a Trial

Patent: 06143664
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 5963
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 19353
Estimated Expiration: ⤷  Try a Trial

Patent: 30981
Estimated Expiration: ⤷  Try a Trial

Patent: 60835
Estimated Expiration: ⤷  Try a Trial

Patent: 61236
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1299821
Estimated Expiration: ⤷  Try a Trial

Patent: 070086924
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 60811
Estimated Expiration: ⤷  Try a Trial

Patent: 08216
Estimated Expiration: ⤷  Try a Trial

Patent: 10840
Estimated Expiration: ⤷  Try a Trial

Patent: 49763
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KYPROLIS around the world.

Country Patent Number Title Estimated Expiration
Hong Kong 1231491 用於抑制蛋白酶體的化合物 (COMPOUNDS FOR PROTEASOME ENZYME INHIBITION) ⤷  Try a Trial
Poland 3101026 ⤷  Try a Trial
Russian Federation 2006140251 СОЕДИНЕНИЯ ДЛЯ ИНГИБИРОВАНИЯ ФЕРМЕНТОВ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KYPROLIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1781688 122016000032 Germany ⤷  Try a Trial PRODUCT NAME: CARFILZOMIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688 2016/013 Ireland ⤷  Try a Trial PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688 PA2016010,C1781688 Lithuania ⤷  Try a Trial PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.